When high-quality total mesorectal excision is performed, does adding short-course preoperative radiotherapy reduce local recurrence? [Dutch TME Trial]
When high-quality total mesorectal excision is performed, does adding short-course preoperative radiotherapy reduce local recurrence?
Absolute Effect
The principal randomized evidence established local-control benefit; the trial did not demonstrate a major overall-survival advantage attributable to RT. Later follow-up confirmed that improved local control did not automatically translate into OS improvement.
Absolute effect: Five-year local recurrence was 4.6% with RT+TME versus 11.0% with TME alone: absolute reduction 6.4 percentage points.
NNT: 16, based on 5-year local recurrence (absolute reduction 6.4 percentage points).
NNH: not quantifiable from the cited recurrence analysis because a single comparable fixed-time serious toxicity endpoint was not reported.
Follow-up: Median follow-up 7.0 years in the detailed recurrence-pattern analysis.
Clinical results and treatment burden
- Intervention: TME alone versus short-course preoperative RT 25 Gy in 5 fractions followed by TME.
- Principal toxicity: Preoperative RT adds treatment burden and can affect postoperative function, but the detailed recurrence publication did not provide a single prespecified grade 3–5 toxicity rate suitable for an NNH calculation.
- Other efficacy/recurrence findings: RT reduced local recurrence across subsites; presacral recurrence remained important, particularly with advanced tumours and after abdominoperineal resection.
- Quality of life: Long-term bowel and sexual function were relevant consequences of treatment, but the recurrence analysis was not primarily a QoL trial.
Eligibility and clinical context
1,417 patients with primary rectal adenocarcinoma within 15 cm of the anal verge, without distant metastases, randomized to TME alone or 5×5 Gy preoperative RT followed by TME.
Limitations and maturity: The trial predates modern high-resolution pelvic MRI, routine neoadjuvant systemic therapy and contemporary risk-adapted RT. Its value is foundational: it established the interaction between meticulous TME and preoperative pelvic RT.